Evaluation of the compliance of a clinical trial participant with research protocols, including research goals, typically looks at only one variable at a time. Such evaluation is not empirically derived by quantitative analysis of existing datasets, instead relying on the researcher's or sponsors' judgment and biases to determine whether and what type of corrective action is required. Furthermore, evaluation of compliance of a clinical trial participant with clinical trial protocols has typically not taken into account the domain of the clinical trial or the characteristics of the participants. Finally, such evaluation often cannot be made in a timely way, but is made only after serious noncompliance has already occurred.
Each year, many resources, including money and time, are wasted on clinical trial sites that fail to comply with research protocols, including failure to produce any data, a sufficient amount of data or reliable data. For example, many clinical trial sites provide inaccurate data due to poor training or non-compliance with research protocol. Resources may be devoted to clinical trial sites that fail to enroll a sufficient number of subjects, or even one subject, producing little useful data in view of the amount of resources devoted to setting up the clinical trial. Further, participants in the clinical, such as subjects, trial investigators, research coordinators, site staff, and study monitors, may on occasion falsify data for the trial, possibly resulting in erroneous conclusions and creating liability for the trial's sponsor. Therefore, identification of clinical trial sites or other clinical trial participants that tend to produce results that are adequate in quantity and quality, and those that do not produce adequate results may provide enormous conservation of resources.